Stomach NeoplasmsPhase 2CLASS-04NCT02845986
Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer
A Phase 2 study testing Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections and oxaliplatin in people with Stomach Neoplasms, run by Fujian Medical University at 20 sites in China.
Trial summary
The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections and oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 20 sitesChina
- Study dates
- 1 Sep 2016to 12 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Who cannot join
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
- History of other malignant disease within the past 5 years
Show all 14Show fewer
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
The Second Hospital of Jilin University
Changchun, Jilin, 130041
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Beijing Cancer Hospital
Haidian, Beijing Municipality, 100142
Longyan First Hospital
Longyan, Fujian, 364000
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Jiangsu province hospital
Nanjing, Jiangsu, 210029
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Pudong, Shanghai Municipality, 200135
The First Hospital of Putian City
Putian, Fujian, 351100
Southwest Hospital
Shapingba, Chongqing Municipality, 400038
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, 830054
Shanghai Zhongshan Hospital
Xuhui, Shanghai Municipality, 200032
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000
About this study
Official title: Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Multicenter Phase II Trial
The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.
Read the detailed description
Radical resection is still the primary method of treating advanced gastric cancer.According to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10 lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.
In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has been recognized by more and more surgeons. However, due to the special and complex anatomy of the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open surgery; consequently, the surgery cannot be performed in many centers.
Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions, less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects. Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994, laparoscopic techniques have developed rapidly. The techniques are becoming increasingly mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node dissection. Our center first proposed "Huang's three-step maneuver", a new operative method suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and facilitates its popularization and promotion.
However, it remains a controversial international issue if it is safe and feasible to routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer.A number of retrospective studies have successively confirmed the safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph node dissection.But there is no multicenter prospective studies to identify the results.
Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority study,to explore the safety and feasibility of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.
- Conditions
- Stomach Neoplasms
- Being tested
- Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections, oxaliplatin
- Keywords
- Stomach Neoplasms, Laparoscopy, Spleen-Preserving, No.10 Lymph Node Dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Spleen-Preserving No.10 Lymph Node DissectionsProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma.
oxaliplatinDrug
Also called platinum-based chemotherapy
oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| No.10 lymph node dissections | Experimental | Patients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy. Receives: Procedure: Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall postoperative morbidity rates
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Measured: 30 days
Secondary outcomes (22)
Numbers of No.10 lymph node dissection
Numbers of dissected No.10 lymph nodes
Measured: 9 days
Rates of positive No.10 lymph node
The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes).
Measured: 9 days
3-year overall survival rate
Measured: 36 months
3-year disease free survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Measured: 36 months
Rates of splenectomy
The Rates of splenectomy are defined as the incidence of splenectomy within operation.
Measured: 1 days
Intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Measured: 1 days
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Measured: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
Postoperative pain
Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
Measured: 30 days
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
The variation of cholesterol
The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
The variation of album
The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
The results of endoscopy
The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
Measured: 3 and 12 months
The variation of body temperature
The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
Measured: 8 days
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of prealbumin
The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion12 Oct 2017
- Study completion12 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Southwest Hospital, China, Fujian Provincial Hospital, Zhangzhou Municipal Hospital of Fujian Province, Shanghai Zhongshan Hospital, Meizhou People's Hospital, Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Second Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, Nanfang Hospital, Southern Medical University, Affiliated Hospital of Qinghai University, The First Affiliated Hospital of Xiamen University, RenJi Hospital, West China Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, The First Hospital of Putian City, Putian, Fujian, Longyan City First Hospital
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University Union Hospital
- Investigators
- Changming Huang, Professor, Principal investigator, Fujian Medical University Union Hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845986
- Sponsor's protocol ID
- 2016-01
- Acronym
- CLASS-04
- Status last verified
- Feb 2020
- First submitted
- 15 Jul 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available.
Publications
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
PubMed 21573742Monig SP, Collet PH, Baldus SE, Schmackpfeffer K, Schroder W, Thiele J, Dienes HP, Holscher AH. Splenectomy in proximal gastric cancer: frequency of lymph node metastasis to the splenic hilus. J Surg Oncol. 2001 Feb;76(2):89-92. doi: 10.1002/1096-9098(200102)76:23.0.co;2-i.
PubMed 11223832Chikara K, Hiroshi S, Masato N, Goro M, Yuichi O, Hidetaka O, Hirotoshi A. Association of the number of metastatic perigastric lymph nodes with long-term survival in gastric cancer. Hepatogastroenterology. 2005 Jan-Feb;52(61):277-80.
PubMed 15783049Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
PubMed 10089184Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
PubMed 8180768Hyung WJ, Lim JS, Song J, Choi SH, Noh SH. Laparoscopic spleen-preserving splenic hilar lymph node dissection during total gastrectomy for gastric cancer. J Am Coll Surg. 2008 Aug;207(2):e6-11. doi: 10.1016/j.jamcollsurg.2008.04.027. No abstract available.
PubMed 18656040Okabe H, Obama K, Kan T, Tanaka E, Itami A, Sakai Y. Medial approach for laparoscopic total gastrectomy with splenic lymph node dissection. J Am Coll Surg. 2010 Jul;211(1):e1-6. doi: 10.1016/j.jamcollsurg.2010.04.006. No abstract available.
PubMed 20610241Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.
PubMed 18095269Schwarz RE. Spleen-preserving splenic hilar lymphadenectomy at the time of gastrectomy for cancer: technical feasibility and early results. J Surg Oncol. 2002 Jan;79(1):73-6. doi: 10.1002/jso.10036. No abstract available.
PubMed 11754382Tanimura S, Higashino M, Fukunaga Y, Kishida S, Ogata A, Fujiwara Y, Osugi H. Laparoscopic gastrectomy with regional lymph node dissection for upper gastric cancer. Br J Surg. 2007 Feb;94(2):204-7. doi: 10.1002/bjs.5542.
PubMed 17058319Huang CM, Chen QY, Lin JX, Zheng CH, Li P, Xie JW. Huang's three-step maneuver for laparoscopic spleen-preserving No. 10 lymph node dissection for advanced proximal gastric cancer. Chin J Cancer Res. 2014 Apr;26(2):208-10. doi: 10.3978/j.issn.1000-9604.2014.04.05.
PubMed 24826062Jung MR, Park YK, Seon JW, Kim KY, Cheong O, Ryu SY. Definition and classification of complications of gastrectomy for gastric cancer based on the accordion severity grading system. World J Surg. 2012 Oct;36(10):2400-11. doi: 10.1007/s00268-012-1693-y.
PubMed 22752074Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8.
PubMed 24399492Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
PubMed 16003309Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
PubMed 11091234
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT02845986
- Acronym / sponsor ID
- CLASS-04 / 2016-01
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Laparoscopy, Spleen-Preserving, No.10 Lymph Node Dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Southwest Hospital, China, Fujian Provincial Hospital, Zhangzhou Municipal Hospital of Fujian Province, Shanghai Zhongshan Hospital, Meizhou People's Hospital, Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Second Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, Nanfang Hospital, Southern Medical University, Affiliated Hospital of Qinghai University, The First Affiliated Hospital of Xiamen University, RenJi Hospital, West China Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, The First Hospital of Putian City, Putian, Fujian, Longyan City First Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2020 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.
Detailed description
Radical resection is still the primary method of treating advanced gastric cancer.According to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10 lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.
In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has been recognized by more and more surgeons. However, due to the special and complex anatomy of the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open surgery; consequently, the surgery cannot be performed in many centers.
Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions, less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects. Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994, laparoscopic techniques have developed rapidly. The techniques are becoming increasingly mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node dissection. Our center first proposed "Huang's three-step maneuver", a new operative method suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and facilitates its popularization and promotion.
However, it remains a controversial international issue if it is safe and feasible to routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer.A number of retrospective studies have successively confirmed the safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph node dissection.But there is no multicenter prospective studies to identify the results.
Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority study,to explore the safety and feasibility of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No.10 lymph node dissections | Experimental | Procedure: Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections, Drug: oxaliplatinPatients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
Key exclusion criteria (14 listed)
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Spleen-Preserving No.10 Lymph Node DissectionsAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma. | Procedure or surgery | No.10 lymph node dissections |
| oxaliplatinAlso: platinum-based chemotherapyoxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery. | Drug | No.10 lymph node dissections |
Primary outcome
overall postoperative morbidity rates
Time frame: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
22 secondary outcomes
Numbers of No.10 lymph node dissection
Time frame: 9 days
Rates of positive No.10 lymph node
Time frame: 9 days
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Rates of splenectomy
Time frame: 1 days
Intraoperative morbidity rates
Time frame: 1 days
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to first soft diet
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
Postoperative pain
Time frame: 30 days
The variation of weight
Time frame: 3, 6, 9 and 12 months
The variation of cholesterol
Time frame: 3, 6, 9 and 12 months
The variation of album
Time frame: 3, 6, 9 and 12 months
The results of endoscopy
Time frame: 3 and 12 months
The variation of body temperature
Time frame: 8 days
The variation of white blood cell count
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of prealbumin
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Results publication: PubMed 21573742Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
- Results publication: PubMed 11223832Monig SP, Collet PH, Baldus SE, Schmackpfeffer K, Schroder W, Thiele J, Dienes HP, Holscher AH. Splenectomy in proximal gastric cancer: frequency of lymph node metastasis to the splenic hilus. J Surg Oncol. 2001 Feb;76(2):89-92. doi: 10.1002/1096-9098(200102)76:23.0.co;2-i.
- Results publication: PubMed 15783049Chikara K, Hiroshi S, Masato N, Goro M, Yuichi O, Hidetaka O, Hirotoshi A. Association of the number of metastatic perigastric lymph nodes with long-term survival in gastric cancer. Hepatogastroenterology. 2005 Jan-Feb;52(61):277-80.
- Results publication: PubMed 10089184Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
- Results publication: PubMed 8180768Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
- Results publication: PubMed 18656040Hyung WJ, Lim JS, Song J, Choi SH, Noh SH. Laparoscopic spleen-preserving splenic hilar lymph node dissection during total gastrectomy for gastric cancer. J Am Coll Surg. 2008 Aug;207(2):e6-11. doi: 10.1016/j.jamcollsurg.2008.04.027. No abstract available.
- Results publication: PubMed 20610241Okabe H, Obama K, Kan T, Tanaka E, Itami A, Sakai Y. Medial approach for laparoscopic total gastrectomy with splenic lymph node dissection. J Am Coll Surg. 2010 Jul;211(1):e1-6. doi: 10.1016/j.jamcollsurg.2010.04.006. No abstract available.
- Results publication: PubMed 18095269Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.
- Results publication: PubMed 11754382Schwarz RE. Spleen-preserving splenic hilar lymphadenectomy at the time of gastrectomy for cancer: technical feasibility and early results. J Surg Oncol. 2002 Jan;79(1):73-6. doi: 10.1002/jso.10036. No abstract available.
- Results publication: PubMed 17058319Tanimura S, Higashino M, Fukunaga Y, Kishida S, Ogata A, Fujiwara Y, Osugi H. Laparoscopic gastrectomy with regional lymph node dissection for upper gastric cancer. Br J Surg. 2007 Feb;94(2):204-7. doi: 10.1002/bjs.5542.
- Results publication: PubMed 24826062Huang CM, Chen QY, Lin JX, Zheng CH, Li P, Xie JW. Huang's three-step maneuver for laparoscopic spleen-preserving No. 10 lymph node dissection for advanced proximal gastric cancer. Chin J Cancer Res. 2014 Apr;26(2):208-10. doi: 10.3978/j.issn.1000-9604.2014.04.05.
- Results publication: PubMed 22752074Jung MR, Park YK, Seon JW, Kim KY, Cheong O, Ryu SY. Definition and classification of complications of gastrectomy for gastric cancer based on the accordion severity grading system. World J Surg. 2012 Oct;36(10):2400-11. doi: 10.1007/s00268-012-1693-y.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available.
Related trials for Stomach Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 2
Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Stomach Neoplasms, Immune Checkpoint Inhibitors
Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changming Huang, Professor principal investigator
Fujian Medical University Union Hospital,China
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections and oxaliplatin in people with Stomach Neoplasms, run by Fujian Medical University at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall postoperative morbidity rates (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845986, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.